NCT07176117

Surfactant Using a Supraglottic Airway Device in Late Preterm to Early Term Infants

Surfactant Prophylaxis in LAte Preterm to Early Term Infants Using a Supraglottic Airway Device to Help Improve Outcomes

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 422 (estimated)
• Sponsor: Sharp HealthCare · Academic / Other
• Sex: All
• Age: 33 Weeks – 38 Weeks
• Healthy volunteers: Not accepted

Summary

The purpose of this research is to learn new information that may help other infants that have respiratory distress syndrome and need breathing support after birth. The goal of this research is to see if continuous positive airway pressure (CPAP) alone or CPAP with surfactant administration through a less invasive method via an Airway Device (supraglottic airway device) temporarily placed above the vocal cords is better for treating respiratory distress syndrome in late preterm and early term infants.

Conditions

• Respiratory Distress Syndrome (Neonatal)
• Surfactant

Interventions

Type	Name	Description
PROCEDURE	Surfactant Administration Through Laryngeal or Supraglottic Airway (SALSA)	A single dose of surfactant will be given via Surfactant Administration Through Laryngeal or Supraglottic Airways (SALSA). A supraglottic airway device will be used as a standardized procedure for surfactant administration via SALSA using an AirLife Air-Q.
PROCEDURE	Continuous Positive Airway Pressure (CPAP)	Infants to receive continuation of non-invasive respiratory support will remain on continuous positive airway pressure (CPAP).

Timeline

• Start date: 2025-10-01
• Primary completion: 2030-12-31
• Completion: 2031-06-30
• First posted: 2025-09-16
• Last updated: 2025-09-16

Locations

3 sites across 1 country: United States